Hippocampal Sparing Whole Brain Radiation Versus Stereotactic Radiation in Patients With 5-20 Brain Metastases: A Phase III, Randomized Trial

NCT ID: NCT03075072

Last Updated: 2024-10-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 196 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-10
• Study Completion Date: 2025-09-30

Brief Summary

This research study is studying two different types of radiation as treatment for brain metastases (tumors in the brain that spread from a cancer that originated elsewhere in the body)

Detailed Description

This research study is a Phase III clinical trial. Phase III clinical trials examine the safety and effectiveness of a treatment, often comparing it to another known treatment. In this case, the investigators are specifically looking at differences between two forms of radiation treatment in terms of subsequent quality of life.

In this research study, the investigators are comparing stereotactic (focused, pinpoint) radiation (in which each tumor is narrowly targeted) against whole brain radiation (radiation targeting the entire brain) in the treatment of brain metastases. Currently whole brain radiation is the standard option for patients with 5-20 brain metastases. Stereotactic radiation is the standard option for patients with 1-4 brain metastases. Among patients with 1-4 brain metastases, recently published studies suggest that stereotactic radiation results in fewer neurologic side effects than whole brain radiation. It also yields better quality of life in this population. It remains unknown whether stereotactic radiation improves quality of life in patients with 5-20 brain metastases relative to whole brain radiation. In this study, the investigators seek to determine which of the two methods of study treatment results in a better subsequent quality of life for patients with 5-20 brain metastases.

Conditions

Brain Metastases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Whole Brain Radiation

• MRI will be performed prior to radiation is administered
• A hippocampal sparing approach will be used when possible
• Dose will be 30 Gy in 10 fractions

Group Type: ACTIVE_COMPARATOR

Whole brain radiation

Intervention Type: RADIATION

Treatment of the whole brain with radiation. When possible the hippocampus will be spared from radiation.

Stereotactic Radiation (SRS)

• MRI will be performed prior to radiation is administered
• Radiation will be given in 1-5 fractions (dose depends on the size of the tumor that will be treated)

Group Type: EXPERIMENTAL

Stereotactic radiation (SRS)

Intervention Type: RADIATION

Focused radiation to each individual brain metastasis without treatment of the remainder of the brain.

Interventions

Whole brain radiation

Treatment of the whole brain with radiation. When possible the hippocampus will be spared from radiation.

Intervention Type: RADIATION

Stereotactic radiation (SRS)

Focused radiation to each individual brain metastasis without treatment of the remainder of the brain.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Participants must have a biopsy proven solid malignancy with untreated (by radiation) intracranial lesions radiographically consistent with or pathologically proven to be brain metastases. Patients who have undergone prior systemic therapy are eligible
• Five-twenty intracranial lesions must be present on MRI of the brain
• Age 18-80 years at diagnosis of brain metastases
• Karnofsky performance status of at least 70

Exclusion Criteria

• Participants who have undergone prior radiation for brain metastases.
• Patients who have undergone resection of one or more brain metastases but who have not yet started adjuvant radiotherapy are eligible for the study
• Participants who cannot undergo a brain MRI
• Participants who cannot receive gadolinium (MRI contrast)
• Participants with stage IV-V chronic kidney disease or end stage renal disease
• Participants with widespread, definitive leptomeningeal disease
• Participants with small cell lung cancer, lymphoma, or myeloma
• Participants with a maximum tumor diameter exceeding 5 cm (if not resected)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Ayal Aizer, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayal Aizer, MD MHS

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

16-305

Identifier Type: -

Identifier Source: org_study_id